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| Sponsored by: |
Klinikum der J.W. Goethe Universitaet |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002793 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.
| Condition | Intervention | Phase |
|
Colorectal Cancer Metastatic Cancer |
Drug: fluorouracil Drug: leucovorin calcium |
Phase III |
| MedlinePlus related topics: | Cancer Colorectal Cancer |
| ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Calcium gluconate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY |
| Estimated Enrollment: | 336 |
| Study Start Date: | January 1991 |
OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
Eligibility
| Ages Eligible for Study: | 18 Years to 76 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Primary colorectal cancer with unresectable liver metastases Less than 75% involvement of the liver Radical resection of primary colon or rectal tumor required No local recurrence or extrahepatic metastases No portal vein thrombosis, ascites, or cirrhosis
PATIENT CHARACTERISTICS: Age: 18 to 76 Performance status: Karnofsky 70%-100% Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 4 mg/dL Alkaline phosphatase no greater than 1,200 U/L Coagulation tests normal Renal: Creatinine no greater than 2.5 mg/dL Other: No prior malignancy
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior intra-arterial chemotherapy for liver metastases No prior hepatic chemoembolization At least 3 months since fluorouracil
Contacts and Locations| Germany | |||||
| Klinikum der J.W. Goethe Universitaet | |||||
| Frankfurt, Germany, D-60590 | |||||
| Klinikum der J.W. Goethe Universitaet |
| Study Chair: | Matthias Lorenz, MD | Klinikum der J.W. Goethe Universitaet |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000064871, GER-ALM-03/95, EU-96007 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002793 |
| Health Authority: | United States: Federal Government |
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